Optimzing the Use of Data Standards Calling for Volunteers CDISC Implementation Primer This project, in collaboration with CDISC, will provide new CDISC Implementers a guide to providing study data in standardized format to Regulatory Authorities. There will be an additional focus on academia and technology providers. The deliverable is a "CDISC Primer" (e.g. Wiki, White Paper, slide deck, quickstart guides, etc.) and will be developed to address this need and will be made freely available to the public. Data Standards for Non-interventional Studies This project addresses the challenges that programmers face during creation of the analysis datasets and handling of the data for non-interventional studies. The deliverable is a White Paper documenting the challenges and possible solutions. Want to participate? Contact: workinggroups@phuse.eu

Standard Analyses & Code Sharing Calling for Volunteers Code Sharing (Repository) Establish and maintain a collaboration platform for leveraging crowd-sourcing to improve the content and implementation of analyses for medical research and leading to better data interpretations and increased efficiency in the clinical drug development and review processes. Communication, Promotion, Education Looking for a Co-Lead The success of working group “Standard Analyses and Code Sharing” relies on the acceptance, input, feedback and further development from/by the user community. A main priority will be to develop a Communication Plan that conceptualizes efficient ways to communicate working group progress and results, e.g. white papers, and the call for scripts. It will define target groups, timing, communication channels, and the presentation. GPP in Macro Development Macros provide an effective way to automate and reuse code in a standard and consistent manner across SAS programs. This ability to reuse code means that the use of GPP is particularly important in macro code and we think that there is a need to develop a consensus and document good programming prairies specifically for macro programming. Want to contribute? Contact: workinggroups@phuse.eu